drugset / Trial / NCT00461552
Therapeutic Approaches to HAART-Induced Lipodystrophy
Phase 2
Completed
23 enrolled
University of Texas Southwestern Medical Center
Amylin Pharmaceuticals, LLC. · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
To determine the efficacy and safety of 4 therapeutic interventions on HAART-Induced lipodystrophy. The interventions are: 1) Dietary - the effect of a high carbohydrate vs.a high cis-monounsaturated fatty acid diet. 2) The effect of aerobic exercise with dietary advice. 3) The effect of Omega-3 Fish Oil Capsules. 4) The effect of leptin therapy. These interventions are aimed at improving the metabolic complications of HAART therapy such as elevated lipids, and insulin resistance or diabetes.
Timeline
- Start
- 2003-01
- Primary completion
- 2014-09
- Completion
- 2014-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Leptin | Protein / enzyme biologic | — | Subcutaneous |